DCT

1:24-cv-00732

Exeltis USA Inc v. Lupin Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:24-cv-00732, D. Del., 06/20/2024
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Lupin Pharmaceuticals, Inc. is incorporated and resides in Delaware, and Defendant Lupin Ltd., a foreign corporation, is subject to personal jurisdiction in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) for a generic version of the SLYND® oral contraceptive constitutes an act of infringement of a patent covering a specific method of use for a progestin-only birth control pill.
  • Technical Context: The technology relates to oral contraceptives, specifically an estrogen-free, drospirenone-based pill and a dosing regimen that maintains contraceptive efficacy despite a limited number of missed or delayed doses.
  • Key Procedural History: This is a Hatch-Waxman Act lawsuit triggered by Defendant Lupin’s Paragraph IV certification against the patent-in-suit. It is the second such action between the parties concerning a generic version of SLYND®. A prior action involving 15 other patents proceeded to a bench trial in February 2024 and resulted in a 30-month stay of FDA approval for Lupin's ANDA, which is set to expire in August 2024. Lupin received tentative FDA approval for its generic product in November 2022.

Case Timeline

Date Event
2010-07-28 ’213 Patent Priority Date
2022-11-03 Lupin's ANDA receives tentative FDA approval
2024-02-26 Bench trial begins in prior litigation
2024-04-09 U.S. Patent No. 11,951,213 issues
2024-05-29 Lupin sends Paragraph IV Letter
2024-05-31 Plaintiffs receive Paragraph IV Letter
2024-06-20 Complaint filed
2024-08-21 Anticipated expiration of 30-month stay from prior litigation

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 11,951,213 - "Synthetic Progestogens and Pharmaceutical Compositions Comprising the Same," issued April 9, 2024

The Invention Explained

  • Problem Addressed: The patent identifies drawbacks with existing progestogen-only contraceptives (POCs), including low reliability due to the strict requirement of same-time daily intake and the potential for unscheduled bleeding (Compl. ¶1; ’213 Patent, col. 1:12-24). For drospirenone-based contraceptives combined with estrogen, a problem identified is the high peak plasma concentration (Cmax) after oral intake, which can be associated with side effects and poor tolerance (’213 Patent, col. 2:13-20).
  • The Patented Solution: The invention describes a method of contraception using an estrogen-free drospirenone composition in a specific dosing regimen (24 days of active pills followed by a 4-day inactive period) (’213 Patent, col. 2:35-46). The core of the patented method is that it maintains effective contraception even if a patient delays "up to two non-consecutive scheduled daily oral doses" by up to 24 hours, thereby improving upon the strict compliance required by prior POCs (’213 Patent, Abstract; col. 2:50-57). Clinical data presented in the patent suggests this is achieved while inhibiting ovulation, as demonstrated by progesterone levels remaining low despite delayed pill intake (’213 Patent, Fig. 6a).
  • Technical Importance: The invention purports to offer the safety benefits of an estrogen-free contraceptive while providing a dosing flexibility that improves contraceptive reliability and user compliance, addressing a key market need (’213 Patent, col. 14:20-29).

Key Claims at a Glance

  • The complaint asserts independent claim 1 and reserves the right to assert others (Compl. ¶26; p. 12, n.1).
  • Independent Claim 1 requires:
    • A method for providing effective contraception over a 28-day period.
    • Administering 24 scheduled daily oral doses of a pharmaceutical composition comprising 2 mg to 6 mg of drospirenone within a 24-day period.
    • This is followed by a 4-day period of non-administration.
    • The pharmaceutical composition does not comprise estrogen.
    • Administration of up to two non-consecutive scheduled daily oral doses may be delayed up to 24 hours from the scheduled administration.
    • Effective contraception is maintained when the up to two non-consecutive scheduled daily oral doses are delayed.

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is Lupin’s proposed generic version of SLYND®, as detailed in its Abbreviated New Drug Application (ANDA) No. 216936 (the “Lupin ANDA Product”) (Compl. ¶2).

Functionality and Market Context

  • The Lupin ANDA Product contains 4 mg of drospirenone as the active ingredient and is represented as being bioequivalent to the reference listed drug, SLYND® (Compl. ¶¶41, 43, 46).
  • The complaint alleges that the proposed label for Lupin’s product will instruct its use for the same indication as SLYND®: preventing pregnancy in females of reproductive potential (Compl. ¶44, ¶47).
  • Critically, the complaint alleges that the proposed label for the Lupin ANDA Product will instruct a 24/4 dosing regimen and will further instruct that contraceptive efficacy is maintained even if a patient delays taking up to two non-consecutive daily doses by up to 24 hours (Compl. ¶¶48-50). The complaint includes a visual excerpt from the SLYND® label, which the Lupin label is expected to mirror, instructing a user who misses one active pill to "Take it as soon as you remember" and stating, "You do not need to use a back-up birth control method if you have sex" (Compl. ¶34). This visual from the complaint provides an example of instructions for a missed dose while maintaining contraception.

IV. Analysis of Infringement Allegations

’213 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for providing effective contraception in a female patient over a 28-day period... The proposed label for the Lupin ANDA Product will instruct its use for preventing pregnancy. ¶47 col. 61:16-17
...comprising administering 24 scheduled daily oral doses of a pharmaceutical composition comprising from 2 mg to 6 mg of 6β,7β:15β,16β-Dimethylene-3-oxo-17a-pregn-4-ene-21,17-carbolactone to the female patient within a 24-day period, followed by a 4-day period wherein the daily oral dose is not administered... The proposed label will allegedly instruct physicians and patients to administer 24 daily 4 mg oral doses of the Lupin ANDA Product, followed by a 4-day period of non-administration. ¶48 col. 61:18-24
...wherein the pharmaceutical composition does not comprise estrogen... The Lupin ANDA Product is alleged to not contain estrogen. ¶51 col. 61:25-26
...and wherein administration of up to two non-consecutive scheduled daily oral doses may be delayed up to 24 hours from the scheduled daily administration, and the effective contraception is maintained when the up to two non-consecutive scheduled daily oral doses are delayed. The proposed label will allegedly instruct that up to two non-consecutive daily doses may be delayed up to 24 hours and that effective contraception is maintained when such a delay occurs. ¶¶49-50 col. 61:27-32

Identified Points of Contention

  • Scope Questions: As the infringement action is based on the filing of an ANDA, the central issue is one of induced infringement. A primary question will be whether the final approved label for Lupin's product instructs users to perform each and every step of the claimed method. The complaint alleges the Lupin label will mirror the SLYND® label, but the provided visual evidence only explicitly covers a single missed dose, not "up to two non-consecutive" doses as required by the claim (Compl. ¶34). This raises a potential factual question about whether the proposed label will fully map onto the claim language.
  • Technical Questions: The dispute may center on the meaning of "effective contraception is maintained." The complaint alleges the proposed label will instruct this (Compl. ¶50), and the SLYND® label provides support by stating no back-up method is needed for one missed pill (Compl. ¶34). A question for the court is whether such an instruction satisfies this claim limitation, or if a higher, more explicit standard of proof or instruction is required.

V. Key Claim Terms for Construction

  • The Term: "effective contraception is maintained"
    • Context and Importance: This term defines the functional outcome of the method and is a lynchpin of the invention's purported improvement over prior art. Its construction will be critical for determining whether the instructions on Lupin's proposed label induce infringement. Practitioners may focus on this term because it links the act of delaying a dose to a specific clinical result, which could be a point of attack for a defendant arguing non-infringement or invalidity.
    • Intrinsic Evidence for a Broader Interpretation: The patent specification states that the compositions "will exhibit a higher contraceptive reliability than other progestogen only pills, which will allow the patients to be less compliant with treatment without risking unwanted pregnancy" (’213 Patent, col. 14:24-29). This suggests the term should be understood in its plain and ordinary sense of preventing pregnancy.
    • Intrinsic Evidence for a Narrower Interpretation: The patent provides detailed clinical trial data, including specific progesterone levels used to confirm ovulation inhibition despite missed doses (’213 Patent, col. 12:5-20; Fig. 6a). A party could argue that "effective contraception is maintained" should be narrowly construed to require the specific levels of ovulation inhibition demonstrated in the patent's own examples.

VI. Other Allegations

  • Indirect Infringement: The complaint is premised on theories of indirect infringement. It alleges that Lupin will induce infringement by physicians and patients because its proposed product label will instruct them to perform the patented method (Compl. ¶¶75-79). The complaint also pleads contributory infringement, alleging the Lupin ANDA Product is especially made for infringing the patent and is not suitable for a substantial non-infringing use (Compl. ¶80).
  • Willful Infringement: Willfulness is alleged based on Lupin’s knowledge of the ’213 patent, which it allegedly gained no later than May 29, 2024, the date it sent its Paragraph IV Letter (Compl. ¶¶55, 58). The complaint alleges Lupin's infringement is willful and seeks enhanced damages and attorneys' fees (Compl., Prayer for Relief F, G).

VII. Analyst’s Conclusion: Key Questions for the Case

  • A central evidentiary question will be one of instructional equivalence: Will the final, approved label for Lupin's generic product contain instructions that meet every limitation of Claim 1? Specifically, does it instruct on a regimen that maintains efficacy after "up to two non-consecutive" delayed doses, or do its instructions cover a narrower scenario, creating a potential mismatch with the claim scope?
  • The case will also turn on a question of definitional scope: How will the court construe the term "effective contraception is maintained"? Whether this term is given its plain meaning or is tied to the specific clinical endpoints detailed in the patent specification will be critical to both the infringement and potential validity analyses.
  • A key procedural question will be the influence of prior litigation: Given the extensive litigation history between the parties over the SLYND® patent portfolio, a significant issue will be how arguments, evidence, and any claim construction rulings from the "First Action" may inform the strategy and outcome of this case involving a newly-issued but closely related patent.